Careers

Search Jobs Connect With Us

Senior Manager of Regulatory Affairs

Job Attributes

Job Id:

21668

Job Category:

Clinical & Life Sciences

Job Location:

Rockville, MD  20850

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Life Sciences is currently seeking a Senior Manager of Regulatory Affairs in Rockville, MD to support a major medical device research and development and manufacturing organization. The Senior Manager of Regulatory Affairs will provide integral support to domestic and international medical device regulatory submissions, as well as act as the main point of contact between the organization and key decision-makers at the FDA and governing bodies.

 

Responsibilities of the Senior Manager of Regulatory Affairs:

  • Serve as main point of contact for all regulatory, quality assurance (QA), research and development, and other departments to provide updates towards regulatory submission status
  • Develop and provide global strategy towards in vitro diagnostic device (IVD) regulatory submissions (PMA, 510k, etc.)
  • Utilize current knowledge of international class III regulatory affairs for medical device to prepare and submit 510k and PMA submissions
  • Lead regulatory affairs update and product change delivery for entirety of department

Requirements for the Senior Manager of Regulatory Affairs:

  • 3+ years of experience with in vitro diagnostic device (IVD) regulatory affairs
  • Experience with pre-market approval (PMA) and 510k regulatory submissions  
  • Ability to interact with FDA representatives to ensure proper regulatory submissions
  • Bachelor’s Degree in related field

Compensation for the Senior Manager of Regulatory Affairs:

  • Salary: $125,000+, commensurate with experience
  • Benefits: Medical, Dental, Vision, 401k, paid time off, holidays, potential for annual bonus

 

Please send all qualified resumes to Michael Epstein at mepstein@pipercompanies.com.

 

 

 

Keywords: in vitro diagnostic device, IVD, pre market approval, pma, regulatory specialist, fda, food and drug administration, regulatory submission, class iii, class 3, medical device, pharmaceutical, cell therapy, diagnostics, domestic, international, medical, dental, vision, 401k, paid time off, paid holidays, eumdr, European medical device regulations

Apply Now

CONTACT INFORMATION (Required)
RESUME (Required)
No file selected
x
Formats accepted: .doc / .docx / .pdf / .txt
Don't have a resume? Click here to fill out a short form.

Copy/paste your resume inside the text editor below:

ADDITIONAL INFORMATION (Required)
WORK HISTORY (Required)
Add another experience (optional)
EDUCATION (Required)
Add another degree (optional)
SKILLS (Required)
Add another skill (optional)

The following error(s) occurred:

Please wait while your job application is being processed. This may take a few moments.
New Search

Job Id:

21668

Job Category:

Clinical & Life Sciences

Job Location:

Rockville, MD  20850

Security Clearance:

No Clearance

Business Unit:

Piper Companies